Oral Solid Dosage Forms (Baseline Guide, Volume 2)

This revision - the latest ISPE publication reviewed by the US FDA - updates content from the original Oral Solid Dosage Forms Baseline® Guide to current industry standards, practices, and regulatory requirements. Specifically, it addresses the latest interpretation of GMP requirements, as well as a risk-based approach to regulatory compliance relating to the design, construction, and validation of the OSD manufacturing facility. The product and processing chapter has been expanded with detailed discussion of each critical unit operation and new technological trends, such as continuous processing and implementation of process analytical technology. The Guide provides a comprehensive view of best practices available in the pharmaceutical industry for oral solid manufacturing facility design and construction. A lifecycle approach to project management is emphasized.